Shock and awe: they did it! A few days after the United Kingdom voted to leave the European Union, many sectors are investigating the consequences thereof for the services and products concerned. The more a sector has been regulated at an EU level, the more severe those consequences tend to be.

Although it is difficult to imagine that years of laws and case law can be cast by a vote, strictly speaking the European Regulations will cease to apply in the United Kingdom once it no longer forms a part of the EU. Also, there will no longer be an imperative to implement European Directives into English national law. Access for European nutraceuticals to the UK market and access for English nutraceuticals on the EU market will therefore depend on the instruments replacing the common European framework.

What are the options?

Firstly, the UK could reach and agreement similar to the one that the EU has with Norway or Iceland. In that case, the impact in the field of nutraceuticals would be fairly limited; the UK forming part of the European Economic Area and to a large extent be bound by EU legislation. Secondly, if the relationship would be shaped after the one between the EU and Switzerland, the implications could be more important, as EU food law would not be of general application in the UK. Thirdly, the gap between the current and future situation would be even greater if the relationship will be similar to the one that the EU has with the USA under the WTO, as for each specific sector specific agreements would need to be negotiated.

The trigger and the transition period

In order to move to the next stage, the UK will have to inform the Council of its decision to withdraw from the European Union, based on the famous article 50 of the Lisbon Treaty. So far, the UK seems to be divided on the question when this process has to be initiated. Some (Europeans) speculate that it may not be initiated at all. However, once the Council has received notice from the UK, an agreement setting out the arrangements for withdrawal should be negotiated within two years. During this transition period, the EU regulatory framework for nutraceuticals shall – in principle – remain in force. However, it can be expected that food business operators shall anticipate on the shift in the regulatory landscape. The UK may become less attractive to trade nutraceuticals due to the uncertainly what will be the applicable rules there.

Open ends… or not?

Based on the EU regulatory framework, nutraceuticals generally do not require prior market approval. This implies that English nutraceuticals could in principle still be marketed in the EU after the Brexit becoming effective. However, any English nutraceuticals marketed in the European Union will have to meet the EU requirements regarding the type of vitamins and minerals that may or may not be used in food supplements and fortified foods respectively. Furthermore, English nutraceuticals to be marketed in Europe may only use those nutrition and health claims that have been authorized at an EU level and that bear information on ingredients and nutrition facts in line with the Food Information to Consumers Regulation. The other way round is much less clear, meaning that it will remain an open question for quite some time with what rules European nutraceuticals to be marketed in the UK will have to comply . This will depend on the rules applicable to nutraceuticals in the UK replacing the EU regulatory framework. Summarizing it seems that trading UK nutraceuticals in the EU will not become “easier” from a UK perspective, whereas marketing European nutraceuticals in the UK will become less attractive because of the regulatory flaw.

Homework on IP licenses

For those food business operators distributing nutraceuticals under license in the licensed territory of the European Union, it is mandatory to clarify whether or not that territory still includes the EU after a Brexit becoming effective. This will not only depend on the wording of the agreement but also on the trademark backing the license. If this is for instance an EU trademark (former Community Trademark), this will no longer be valid in the UK in future. Moreover, if the validity of this EU mark was mainly based on genuine use in the UK, the validity of the entire trademark could be at stake because such use would no longer be of relevance for the continued existence of the mark.

Conclusion

The majority of the British people do not seem to have done a favor to the nutraceuticals industry, to put it mildly. In order for English nutraceuticals to access the EU market, these products will have to meet the EU standards anyway. For European nutraceuticals to be marketed on the Brittish market however, it cannot yet be predicted to what rules they need to comply. It does not seem to be realistic that the UK will opt for the Norwegian model, as it deliberatly moved away from the EU and – presumably – from the EU regulatory framework. It is also hard to conceive that the UK, being such an important trade partner of the EU will put in the same position as the US under the WTO. Remains the Swiss model as a most likely option for the trade agreements to be negotiated between the EU and the UK, but the Swiss model currently also implies the free movement of persons, which is an issue for the UK. So this is not an easy one. Keep you posted.

Photo by Tolga Akmen/LNP/REX/Shutterstock (5738024r) Pro-EU campaigners protest against Britain leaving the European Union in Trafalgar Square – London Stays anti-Brexit demonstration, Trafalgar Square, London, UK – 28 Jun 2016. The referendum was won by the leave campaign and caused Prime Minister David Cameron to resign on 23 June 2016.

This year marked the 20th anniversary of VitaFoods Europe. This is a global nutraceutical event, where the whole industry gathers to meet, talk, listen and do business. Axon Lawyers again participated in this event, which took place from 10 – 12 May in Geneva, by giving four presentations. Below, you will find a short wrap up of each of them as well as the slides belonging thereto.

B2C Communications in the functional food and nutraceutical sector

Each and any food business operator loves to communicate the benefits of its products, especially in the functional food and nutraceutical sector. However, a strict regulatory framework applies to such communication, which has been largely harmonized at EU level.

For instance, when using nutrition and health claims, one should make sure the authorized wording (or any permitted variation) is used, as well as that the conditions for use are met. Furthermore, one should know that regarding food for special medical purposes, the use of health claims is prohibited. It thereby does not make a difference whether the marketing is targeted at health care professionals or at consumers/patients. Finally, one should avoid making medical claims for food products, including functional foods.

The presentation shows that, based on the presentation of functional foods, it is not always easy to tell whether it is a food product or a medicinal product. Guidance is provided how to prevent a food product to qualify as medicinal products in order to prevent fines for unauthorized marketing of medicinal products.

The marketing of functional food to children requires intimate knowledge of the applicable legal framework, both at an EU and at a national level. This presentation starts with a bird’s eye view on the topic, based on the recommendations of the WHO on the responsible marketing of foods and non-alcoholic beverages to children.

Subsequently the EU framework embodied in the Regulations on Health & Nutrition Claims, Food Information to Consumers and Food for Special Groups is discussed, where concrete examples of authorised claims for specific products are discussed.

Finally, it is explained that in various Member States, self-regulatory bodies such as the Advertising Code Committee in the Netherlands and the Advertising Standards Agency in the UK, play an important role in the evaluation of marketing campaigns of functional food products targeted at children. Again, concrete examples are provided by way of guidance.

The aim of the new EU Clinical Trials Regulation (‘CTR’), which is applicable from 28 May 2016, is to ensure that Member States base their assessment of an application for authorisation on identical criteria throughout the EU. Furthermore, it aims to create an environment that is favourable for conducting clinical trials in the EU with the highest standards for patient safety.

The CTR applies to all clinical trials conducted in the European Union. It does not apply to non-interventional studies. The CTR covers investigations in relation to humans intended to:

discover or verify effects of one or more medicinal products;

identify any adverse reactions to one or more medicinal product;

study absorption, distribution, metabolism and excretion of one or more medicinal products to ascertain the safety or efficacy.

So, what is the relevance of the CTR for nutraceuticals, as only medicinal products are covered by the CTR? Although there is no legal definition of ‘nutraceutical’, the word was introduced in 1989 as a portmanteau of the words ‘nutrition’ and ‘pharmaceutical’. Thus, nutraceuticals blur the line between food and drugs and it is often difficult — by legal definition — to distinguish between nutrients, food additives, drugs and nutraceuticals. The presentation discusses relevant case law concerning the food/drug borderline and provides the highlights of the new CTR from that perspective.

Like last year, alternative proteins were all over Vitafoods. Reasons for the development of alternative sources of protein are easy to point out: health, sustainability and animal welfare. In October 2015, the WHO published a scientific report in which the following was concluded: ‘Consumption of processed meat increases colon cancer risk.’ In the Netherlands, the Dutch Health Council promotes a diet containing more plant based than animal derived proteins.

Eating less meat – and animal derived protein – is also better for the environment as the current production methods require too much natural resources. Last but not least, if meat consumption decreases this is positive for animal welfare. Not only because less animals are slaughtered, but the risk to outbreaks of diseases such as swine fever decreases. Therefore, today there are many alternatives to the consumption of meat.

In the presentation some alternative protein products, such as products containing algae, mushrooms or insects are discussed in the light of the new Novel Foods Regulation as food products may be qualified as “novel” and therefore require authorization under the EU Novel Foods Regulation.

Botanicals are preparations made from plants, algae or fungi that are applied for uses in cosmetics, pharmaceuticals and food supplements. These products have become widely available in the EU and can be bought OTC in pharmacies, supermarkets, drug stores and via the Internet. As to foods supplements, typically these products are labelled as “natural foods” and they come along with various claims regarding potential health benefits. The authorization of health claims for botanicals is still pending in the EU, meaning that they have been neither authorized nor rejected. A recent case from the appeal body of the Dutch Advertising Code Committee perfectly demonstrates the room for manoeuvre for this type of claims.

Green coffee extract

The Dutch online store www.vitaminesperpost.nl offered for sale the product “Green Coffee Plus Extra Strong”, consisting of a green coffee extract, to which was added an extract from green tea and artichoke. The product was a food supplement advertised as being a powerful formula for fat burning, based on its high contents of chlorogenic acid. The Dutch Advertising Code Committee received a complaint regarding this product, as its allegedly beneficial properties could not be substantiated. Complainant had consulted the Natural Medicines Comprehensive Database regarding all 3 ingredients, but did not find any support for the claim regarding fat burning. Complainant considered the claim misleading and therefore unfair.

Authorized use of “claims on hold”

The Dutch branch organization for marketing health products (KOAG/KAG) currently permits the use of health claims for botanicals under certain conditions. The advertiser should be able to produce the EFSA ID number under which the claim is on hold, as well as the conditions of use and the recommended quantity per day of the ingredient at stake. Furthermore, when the use of such claim is disputed, the advertiser using it should be able to substantiate it. In the case at hand, the FBO selling Green Coffee Plus Extra Strong deduced from EFSA’s on hold claims database that it was permitted to associate at least green tea and artichoke with weight control and / or digestion.

Substantiation of claims made

In first instance, the Advertising Code Committee recognized the claim “stimulates fat burning” as a health claim, whereas it was not immediately obvious to which of the three ingredients this claim was linked. Due to the applicable transition regime with respect to the “on hold” claims for botanicals, it did not consider this claim to be in violation of the Health Claim Regulation. The Dutch Advertising Code Committee insisted however that the advertiser of the product Green Coffee Extra Strong substantiates its claim regarding fat burning. The plausibility of the claim made does not automatically follow from the fact that certain ingredients are placed on EFSA’s on hold database. As the advertiser did not succeed to provide the required evidence, his advertisement was considered incorrect. On the basis of this incorrect information, consumers might be inclined to buy the product, which is why the advertising was also considered misleading and therefore unfair.

From green coffee to green tea

On appeal, it became clear that the advertiser was aware that it was not allowed to make any health claims for green coffee. It had therefore added to its product a green tea extract for the minimum conditions of use to obtain the claimed effect. The advertiser clarified that the claim for fat burning was specifically linked to green tea. The Appeal body established that for green tea, a number of claims were on hold in connection with “weight management” and “fat metabolism”. It furthermore established that for such claims to be lawfully used under the transition regime captured by article 28.5 of the Health Claims Regulation, the following conditions should be met:

the claims should not be misleading (article 3 Claims Regulation);

the claims must be based on generally accepted scientific evidence (article 6 Claims Regulation); and

the claims should be in compliance with national legislation.

Anticipating authorization procedure

When an advertiser uses an “on hold” claim and without reservation claims a particular effect, it in fact anticipates the outcome of the authorization procedure pertaining thereto. In such situations, said advertiser should be able to substantiate the claim when disputed. The rationale thereof is that the Health Claims Regulation aims to maintain a high level of consumer protection (article 1 Health Claims Regulation) and in general advertisers should be able to substantiate their claims (article 17 Health Claims Regulation). Once again, it was established that the advertiser was not able to do so and therefore its use of the claim regarding fat burning was considered misleading. The fact that he was also using the disclaimer that Green Coffee Extra Strong was not a miracle product and that it should be used as in support of a healthy diet and sufficient physical exercise, could not change this conclusion.

Negative EFSA opinion

Moreover, it appeared that EFSA had published a negative opinion stating that there was no relationship of cause and effect between the consumption of green tea and green coffee and fat burning. Basically, this was the end of the story, as EFSA had declared that substantiation of claim with respect to fat burning in relation to green coffee and/or green tea could simply not be delivered.

Conclusion

Under the current regulatory framework, it is not allowed to use health claims for botanicals, provided that the conditional character of such claims is clearly communicated. Before using any such claim, it is furthermore recommended to check if it is not covered by a negative EFSA opinion. Finally, when the claim made is being disputed, the advertiser should be able to substantiate it.

This contribution aims to provide you with a brief overview of the EU Organic legislation and recent developments. Being able to market products as ‘organic’ could be a plus for the food business operator (FBO) as the demand for sustainable production and organic food increases. This contribution focuses on the EU-system of organic certification of food products and will specifically look at the position of organic microalgae manufactured in the EU. Under the current legislative framework, these could not be marketed as such in the EU. This has changed since an interpretative note of the Commission of last summer. If you are an FBO interested in marketing organic microalgae, this for sure is of interest to you.

Organics Regulation – scope

First of all, what is ‘organic production’? According to recital 1 of the Organics Regulation organic production is: “(…) an overall system of farm management and food production that combines best environmental practices, a high level of biodiversity, the preservation of natural resources, the application of high animal welfare standards and a production method in line with the preference of certain consumers for products produced using natural substances and processes” (see also the definition in Article 2(a)).

What is covered by the Organics Regulation? Only agricultural plants, seaweed, livestock, aquaculture and animals are regulated under the Organics Regulation. For example, if an FBO wants to produce organic seaweed, all the processes have to be in compliance with the Organics Regulation. This approach is known as the ‘farm to fork approach’, which means every step in the production process throughout the supply chain has to comply with the Organics Regulation.

Organics Regulation – structure

The Organics Regulation has a layered structure. The following three layers of provisions can be found:

General production rules (articles 1, 7 – 10), which apply to all forms of organic production.

Production rules for different sectors (articles 11 – 21): general farm production rules and production rules for specific categories of products and production rules for processed feed and food.

Detailed production rules (article 42).

If there are no production rules for the sector (layer 2), only the general production rules (layer 1) apply.

Organics certificate

Compliance with the Organics Regulation has to be demonstrated by obtaining certificates from a certification body. (See the following link for a list of competent certification bodies in different Member States). In the event a certification body audits the FBO marketing organic products and it encounters violations of the Organics Regulation, it can decide to block certain non-compliant batches of products pending an investigation. Depending on the outcome, the certification body can subsequently decide to withdraw the certificate. If the certificate is withdrawn, the FBO is no longer allowed to market the products as ‘organic’. In case of severe violations, the competent authority may impose a recall of the products. In the Netherlands, Skal Biocontrole is the designated Control Authority responsible for the inspection and certification of organic companies in the Netherlands, within the context of Regulations: (EC) Nr. 834/2007 (Organics Regulation), (EC) Nr. 889/2008 and (EC) Nr. 1235/2008 (import of organic products from third countries). Skal monitors the entire Dutch organic chain on behalf of the Dutch Ministry of Economic Affairs.

The EU organic logo

The EU logo is regulated in a separate Commission Regulation. The main objective of the European logo is to make organic products easier identifiable by the consumers. Furthermore it gives a visual identity to the organic farming sector and thus contributes to ensure overall coherence and a proper functioning of the internal market in this field. For practical information regarding the EU logo, see this link and this link.

Organic microalgae

Prior to July 2015, FBO’s could not obtain an organic certification for microalgae manufactured within the EU for the use in their food products. FBO’s from third countries (non-EU) could market their products in the EU based on either the import procedure as set out in Article 33 (2) (import from recognised third countries) or the import procedure laid down in Article 33 (3) of the Organics Regulation (import of products certified by recognised control bodies). The strange situation was created where ‘organic’ microalgae could only be imported into the EU and not be produced within the EU.

How come? All agricultural products were considered to fall within one of the different production rules for specific categories of products (layer 2) and microalgae for food production were not included. Furthermore, detailed EU production rules for microalgae were absent (layer 3). (Article 42 (2) Organics Regulation).

The Interpretative note of the European Commission (Directorate-General for Agriculture and Rural Development) of July 2015 opened up the possibility for companies in both EU Member States and third countries to produce microalgae, which can be marketed as ‘organic’ and carry the EU organic logo. Both the existing production rules for plants (Article 12 Organics Regulation) and seaweed (Article 13 Organics Regulation) could be suitable for microalgae.

‘Until an implementing act adopted on the basis of Article 38 (of Regulation 834/2007) has clarified the situation, operators producing organic micro algae (except for use as feed for aquaculture) have therefore to comply with the general production rules, which apply to all forms of organic production (“layer 1”) and with the production rules for the sector of plants or seaweed (“layer 2”).’

The use of microalgae as feed for aquaculture is not covered in the Interpretative note, as microalgae as feed are already subject to the detailed production rules. The rules for the collection and farming of seaweed apply according to Article 6a of Commission Regulation (EC) No 889/2008.

The interpretation opens up the possibility to certify microalgae to be used as food (or as an ingredient in food) as being organic. When an implementing act will be published and enter into force is still unknown. A proposal for a new Regulation repealing the Organics Regulation has been published. On 5 November 2015 a report from the Committee on Agriculture and Rural Development on the proposal was published, introducing 402 amendments. The current status of the proposal is available through this link.

Aside from enforcement by a national control authority in case of non-compliance with the Organics legislation, consumers and other interested parties often also have the possibility to lodge a complaint relating to advertising of organic products. However, advertising of (organic) products is a topic to be covered in another contribution on Food Health Legal. Stay tuned!

Some food supplements claim to help the consumer to lose weight and achieve the ideal bodyweight by consuming the product. Sounds too good to be true? Then this post is of interest for you. Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies (NDA Panel) was asked to provide a scientific opinion on the conditions of use for health claims related to meal replacements for weight control. In fact, the NDA Panel previously evaluated the conditions of use for these types of claims in 2010. We take this re-evaluation as an opportunity to report on the legal framework for weight loss claims regarding foodstuffs.

Relevant legal framework

The relevant legal framework is constituted by both the Health Claim Regulation and the Energy Restricted Diets Directive. Article 12 of the Health Claim Regulation prohibits the use of claims making reference to the rate or amount of weight loss. According to article 13 of the Health Claim Regulation however, it is permitted to use health claims describing slimming or weight control or a reduction in the sense of hunger. It is also permitted to use claims describing an increase in the sense of satiety or the reduction of the available energy from the diet. For these claims to be allowed, they should be in line with the requirements of the Energy Restricted Diets Directive (containing both compositional and labeling requirements) and they should be included in the Community list of permitted claims. Furthermore, these claims should be based on generally accepted evidence and they should be well understood by the average consumer.

Various claims allowed regarding normal metabolism

The consumer could be helped in achieving weight reduction by consuming products that replace some of the daily need for energy or that reduce the craving for more food. In fact, maintaining a healthy metabolism (of either lipids or carbohydrates) could result in weight loss on the long term. There are quite a few authorized claims relating to a normal metabolism. For instance, the claim “Zinc contributes to normal carbohydrate metabolism” can be used if the product to which it relates contains zinc in a quantity of 1,5 mg/100 g or 0,75 ml/100 ml. Furthermore, the claim “Calcium contributes to normal energy-yielding metabolism” is allowed if it relates to a product contains at least 120 mg/100 g calcium or 60 ml/100 ml Calcium. As a final example, the claim “Choline contributes to normal lipid metabolism” can be used if the food product at stake contains at least 82,5 mg of choline per 100 g or 100 ml or per single portion of food.

One single authorized claim regarding weight loss

Until now only one single claim with respect to weight loss has been authorized. The claim reads “Glucomannan in the context of an energy restricted diet contributes to weight loss”. Glucomannan is extracted from a plant called “konjac”, having very diverse nicknames, such as devil’s tongue or snake palm. The claim regarding Glucomannan is targeted at overweight adults and may be used only for food products that contain 1 g of glucomannan per quantified portion. Furthermore, the consumers should be informed that the beneficial effect is obtained with a daily intake of 3 g of glucomannan in three doses of 1 g each, together with 1-2 glasses of water, before meals and in the context of an energy-restricted diet.

Two authorized claims for meal replacement

Next to the Glucomannan-claim, there are two claims available for foodstuffs replacing one respectively two meals a day. Both claims are identical and read “Meal replacement for weight control”. Where nutrition and health claims in general are linked to particular nutrients, this claim however is not. In order to achieve the claimed effect, one meal respectively two meals should be substituted with meal replacements daily. Furthermore, foodstuffs bearing this claim should comply with specifications laid down in Energy Restricted Diets Directive. This Directive sets minimum and maximum limits for nutritional values of foodstuffs that are consumed as a replacement for one or two meals a day. Furthermore, this Directive prescribes the content of replacement products, in terms of energy, proteins, dietary fiber, vitamins and minerals. The foods under the Energy Restricted Diets Directive are not to be confused with so-called medical foods. These foodstuffs also regulated in terms of content and labeling and they are also used to replace meals, however only upon prescription and not for the purposes of weight loss.

Re-evaluation of the weight loss claim

The reason for the re-evaluation of the claims regarding meal replacements for weight control is a bit of a technical story. We will try to do our best to explain this in clear and understandable terms. As of 20 July 2016, the Energy Restricted Diets Directive will be repealed by a new Functional Foods Regulation providing a common framework for all types of functional foods: infants foods, medical foods and total diet replacement for weight control. As a consequence, the Annex to the Energy Restricted Diets Directive containing detailed guidance on the composition of foods for energy restricted diets will no longer apply Instead, guidance will have to be taken from the applicable Annex to the Food Information for Consumers Regulation (Annex XIII, Part A to be exact) introducing the Nutrient Reference Values’ for vitamins and minerals. This will cause some changes (increases or decreases) in the micronutrient content of meal replacements to occur.

Task of the NDA Panel

Under both the current and the future legal framework for meal replacements, the foodstuff has to contain specified quantities of certain vitamins and minerals to make sure that even when replacing meals as a whole, the consumer does not suffer a vitamin/mineral deficiency. Normally, the consumer is expected to loose weight on the basis that the replacement meal has a controlled energy content and a relatively high protein/low fat content. The NDA Panel was asked to give its scientific opinion about the substantiation of the health claim related to meal replacements under the new Functional Foods Regulation. The NDA Panel considered that the difference in micronutrient composition required under this new Regulation in respect to the Energy Restricted Diets Directive did not affect the scientific substantiation of said health claim, as previously assessed in 2010. As a consequence, the claim “contributes to weight loss” can still be used, provided of course that the conditions for use are met.

What more is allowed?

With respect to other ingredients and substances than Glucomannan, weight loss or similar claims have been made as well. As examples can be mentioned green tea extract and hyperproteins pasta. EFSA did assess more substances and the related claims and concluded that there was a lack of scientific evidence to substantiate such a claimed effect. Recently the claim; “fat-free yogurt and fermented milks with live yogurt cultures, with added vitamin d, and with no added sugars help to maintain lean body mass (muscle and bone) in the context of an energy-restricted diet” was not approved. In essence, products that carrying the claim, ‘contributes to weight loss’ which do not contain Glucomannan in the prescribed quantities and do not comply with the standards as set in the Energy Restricted Diets Directive, are not allowed on the European market. But with a little education of the consumer, explaining that a normal metabolism is actually at least as important as weight loss, plenty of other claims are available for healthy products. During the festive season, the emphasis may not be on the consumption of healthy products. But on a day-to-day basis, we strive for a healthy intake – or don’t we? That’s the point!

The author is grateful to Floris Kets, intern at Axon Lawyers at the time of drafting this blog.

The heat was on today in the European Parliament (EP). The reason for that was that the new Novel Foods Regulation was put to vote in a plenary session. In the debate prior to the vote, the opinions centred between concerns about food safety and the free circulation of goods. In this post, you will be updated about the outcome of the vote. In short, the adoption of the new Novel Foods Regulation will have important consequences for Food Business Operators (FBO’s). In an earlier post, we already reported about streamlined authorisation procedures. Today, we will mainly focus on the type of products covered by this legislation. Insects are in for a start. In a 10 minutes read, you will learn what are the consequences thereof – and more.

Shaping the new Novel Foods Regulation

Today (28 October 2015), the EP adopted the latest proposal for a Regulation on Novel Foods [insert final text]. As reported in one of our previous posts, the European Commission published an initial proposal for this Regulation in December 2013. EP Rapporteur Nicholson heavily criticised this draft, mainly for its open product definition and for the lack of streamlining the authorisation procedure. As a result, an EP legislative proposal became available, in which the Rapporteur formulated a number of improvements. Most of them were included into the draft legislation approved by the ENVI committee by the end of November 2014, which further developed into the text voted today. This adopted proposal will enter info force after publication in the OJ. However, a transition period of 24 months after such publication has been provided before its actual application.

So what are Novel Foods finally?

In the initial Commission proposal, the various product categories had not been exhaustively defined. Although such a system could present the advantage of flexibility, in fact FBO’s resisted against the legal uncertainty this would create. As a result, the approved draft by the ENVI Committee identified 10 categories of Novel Foods. Some of these have again been heavily debated, like for instance insects – however without success. The Regulation voted today in the EP defines the following products as Novel Foods:

food with a new or intentionally modified molecular structure;

food consisting of or isolated / produced from microorganisms, fungi or algae;

food consisting of or isolated / produced from material of mineral origin;

food consisting of or isolated / produced from plants or their parts, except when the food has a history of safe food use in the Union and one out of two alternative conditions are met;

foods consisting of or isolated / produced from animals or their parts, except where these animals were obtained from traditional breeding practises and the food from those animals has a history of safe food use;

food consisting of or isolated / produced from cell or tissue culture derived from animals, plants, micro-organisms, fungi or algae;

food resulting from a production process not used within the Union before 15 May 1997, giving rise to significant changes in the composition or structure of a food, affecting its nutritional value, metabolism or level of undesired substances;

food consisting of engineered nanomaterials;

vitamins, minerals and other substances, where a new production process has been applied or where they contain engineered nanomaterials;

food used exclusively in food supplements within the Union before 15 May 1997, where it is intended for use other than in food supplements.

What’s in? – Most striking changes

Contrary to the ENVI proposal, the current text of the Regulation no longer mentions food derived from cloned animals or their descendants as a separate product category. However, it becomes clear from the recitals in the new Novel Foods Regulation that no change is intended here. Until specific legislation on food from animal clones enters into force, such food is covered by category nr. 5 of this Regulation, as food from animals obtained by non-traditional breeding practises. Another textual change relates to category nr. 8. Whereas the ENVI draft still specified the highly debated 10 % threshold for a food ingredient to qualify as nano (instead of the 50 % threshold proposed by the Commission), no such threshold is contained in the current text. Although this is no doubt a compromise solution, it is expected it shall give rise to new discussions. A real change with respect to the ENVI proposal relates to product category nr. 3, covering food of mineral origin. For now, the background of this change remains unclear. Finally, insects are still covered by category nr. 4. Today, many food products consisting of or containing insects are marketed in various Member States. It is therefore important to establish what will be the consequences of considering insects as Novel Foods. In order to answer that question, the provisions laying down the transition regime are of interest. Furthermore, by way of background, a number of safety evaluations of insects as food are briefly discussed.

On 8 October 2015, EFSA published its Risk profile related to production and consumption of insects as food and feed ordered by the Commission. In fact, EFSA was requested to assess the micro-biological, chemical and environmental risks posed by the use of insects in food relative to the risks posed by the use of other protein sources in food. EFSA found that for the evaluation of micro-biological and chemical risks, the production method, the substrate used, the stage of harvest, the specific insect species and the method of further processing are of relevance. It established however that with respect to any of these topics, fairly limited data are available. It therefore strongly recommends further research for better assessment of microbiological and chemical risks from insects as food, including studies on the occurrence of hazards when using particular substrates, like food waste and manure.

Transition regime

How to deal with insects as food products that are currently marketed? The new Novel Food Regulation provides first of all that these products do not have to be withdrawn from the market. However, for the continued marketing of such food products a request for authorisation should be filed within 24 months after the date of application of the new Novel Food Regulation. This would come down to the following.

Entry into force of new Novel Foods Regulation: 1 January 2016 (assumption)

Date of application of new Novel Foods Regulation: 1 January 2018

Ultimate date for filing authorisation for continued marketing of insects as food: 1 January 2020.

This means that roughly speaking 4 years from now, FBO’s offering insects as food should still obtain a Novel Food authorisation. Assuming that these products have been marketed since the end of 2014 (see for instance the news on the launch of the insect burger sold by Dutch grocery chain JUMBO), this would mean that they were on the market 5 years before. If no safety concern ever arose so far, it would not be unreasonable to request an exemption from this obligation. At any rate, such FBO’s should know that prior to the indicated date of 1 January 2020, they can most likely successfully rebut any enforcement measures by local food safety authorities.

Conclusion

The adoption of the new Novel Foods Regulation has been a process with quite a few hick-ups and some surprising results. Whereas food from cloned animals for a long time had been the cause of delay, it is surprising to see that this Novel Food category nevertheless ended up within the scope of the new Novel Foods Regulation. As to products providing alternative protein, such as insects, we understand that the safety aspects from rearing to consumption should be carefully assessed. However, we note that EFSA does not have any immediate safety concerns per se. Furthermore, it should be stressed that the notion of “safety” in EU food law has only been negatively defined. That is, food is safe as long as it is was not found unsafe. Therefore, we consider that alternative protein products that were marketed for a number of years without any problems reported should not be subject to further barriers. Anyhow, FBO’s should be aware of their rights of continued marketing of such products, at least for four more years to come.

Want to know more about this subject? Do join the Axon Seminar on Alternative Proteins: invitation seminar.

Image: Amsterdam Westerpark, food festival “The Rolling Kitchens“, serving snacks made out of insects, such as fried grasshoppers on a stick or mealworm spring rolls.

Recent research from the Erasmus medical centre (Netherlands, Rotterdam) suggests that certain medicines might be taken up better by patients when administered with Coca Cola instead of water. In short, the researchers where looking for a way of helping patients who received the medicine erlotinib (Tarceva). The medicine is used to treat lung cancer patients and it is orally administered. Most of the cancer patients also use stomach protection medicines against the side effects of cancer medication. These protection medicines however lower the pH in the stomach and therefore the uptake of erlotinib in the bloodstream was not optimal. Taking the medicine with Coca Cola (which creates a temporary more acid environment in the stomach) gave spectacular results: the levels of uptake in the blood were in the average 40 % and sometimes even 100 % higher. Could Coca Cola therefore be considered to be a medicine?

Food or medicine?

At first sight, this question may seem to be somewhat far-fetched, but in this context it is interesting to know that Coca Cola was invented by a pharmacist. Furthermore, the question whether a product qualifies as a food or as a medicine is not highly theoretical. In fact, there is an important body of EU case law since the 80-ies that deals with exactly this question. This is all the more relevant, as the qualification of a food product as a medicinal product can have drastic consequences for market access. This blogpost will discuss a number of those cases, including vitamin preparations and garlic pills, and address the status of Coca Cola against that background.

(a) “any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or

(b) any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.”

According to the General Food Law Regulation, a food means “any substance or product, whether processed, partially processed or unprocessed, intended to be, or reasonably expected to be ingested by humans”

Are vitamin preparations medicinal products?

In order to answer this question, the national authorities should properly assess the pharmacological properties (the “function of the product”) and the presentation of the product. In the Van Bennekom case (C-227/82), relating to a Dutch national trading highly concentrated vitamin preparations in the form of tablets, pills and capsules, the European Court of Justice (“EU Court”) elaborately dealt with the presentation criterion. This was also one of the first cases where the EU Court provided a dividing line to be drawn between medicinal products and food products. In short, the EU Court ruled that the form given to the product (pills, capsules) can serve as strong evidence of the intention of the manufacturer or seller to market a medicinal product, but is not conclusive in its own right. However, the concept of presentation with respect to borderline products must be broadly conceived in order to protect consumers. Therefore, a product can qualify as medicinal product if any well-informed consumer, based on the presentation of the product, gains the impression this is actually a medicinal product.

Do Member States differ on the qualification of borderline products?

Yes, they sometimes do. This was clearly demonstrated in the Delattre case (C-369/88). In this case, products that were sold in Belgium as supplements and cosmetics qualified as medicinal products in France. The EU Court ruled that the products were presented as having positive effects on certain body functions, like the functioning of the gastro intestinal tract or liver and therefore, they were covered by the Medicial Products Directive. The French authorities could qualify the products as medicinal products, even if in Belgium these products qualified as foods and cosmetics. The national authorities and courts will have to judge on a case-by-case basis if a product is either a food or a medicinal product. If the product can be qualified as food and or cosmetic and as a medicinal product, the product is considered a medicinal product and not both.

Are Garlic pills medicinal products?

The so-called Garlic case (C-319/05) related to food supplements that were presented in a capsule form. The German authorities qualified these supplements as a medicine, but the EU Court did not agree. Although the supplements had a capsule form, the EU Court ruled that this form is not exclusive to medicinal products. Moreover, the supplements did not contain any mention that they aimed to prevent or treat a certain disease. Furthermore, although the beneficial effect from the active ingredient allicin was recognized, this effect did not transcend the normal metabolism of garlic. Therefore, the food supplements were not considered to be medicinal products, neither by presentation, nor by function.

Qualification of Coca Cola as a medicinal product?

Against the above background, could Coca Cola possibly be qualified as a medicinal product? For sure, it will not qualify as such by presentation. The product is sold in a bottle or as a can in quantities that exceed by far the average medicinal product. It is not recommended for care or cure, but to refresh at most. The qualification by function is a different story, as it does present some positive effects on certain body functions. The Erasmus research has demonstrated that taking the medicine erlotinib (Tarceva) together with a glass of Coca Cola will temporarily lower the pH in the stomach, back to the acidity levels prior to taking any stomach protection. In essence the Coca Cola restores a body function. A regular soft drink does not have this effect and one could therefore argue that Coca Cola does have a medicinal function. The pharmacological properties of Coca Cola as such are not substantial, although the effect in combination with the medicine can be. The boundaries between food and medicinal products are not set in stone but keep on moving.

The author thanks Floris Kets, trainee at Axon Lawyers, who had the great idea for this post.

On 11 September 2015 new legislation amending the current Commodities Act (in Dutch: Warenwet), partly entered into force. Under the new legislation the maximum administrative fine to be imposed on Food Business Operators (hereinafter: ‘FBO’s’) by the Dutch Food Safety Authority (NVWA) is increased dramatically compared to the prior maximum fine. The Dutch legislator has clearly increased existing fines to make them stronger and more effective to increase compliance with food safety regulations. The NVWA has more teeth, but will it bite?

The rationale behind the increased fines

A reason to increase the maximum fines can also be found in the battle against food fraud in general. Until recently the NVWA could impose a fine on an FBO on the basis of Article 32 of the Commodities Act. The maximum fine was set at € 4.500. According to its latest annual report, the NVWA imposed 2808 fines on FBO’s in 2014. The average amount of a fine was € 1.206,– and the total amount of imposed fines was € 3.413.893,–. Considering the costs of compliance with hygiene and administration standards, these penalties are merely peanuts for the average FBO and do not have the desired effect of contributing to compliant behavior as is confirmed by the statement further down in this post.

Fines linked to system under Dutch Penal Code

Fines in other areas such as data protection law are also subject to revision and they will both increase and expand (meaning an increased number of provisions will be subject to potential fines in case of non-compliance and those fines tend to increase as well). With a political climate both in the EU and in the Netherlands that leans towards stronger enforcement instruments, it was just a matter of time before the fines under the Commodities Act would be increased. The Dutch legislator seems to try to harmonize the several fines in different legal acts by referring to the categories of fines specified in the Dutch Penal Code. These categories are linked to the severity of the violation. The first category is the lowest and the sixth category the highest. The maximum fines are now set at the maximum of the sixth category: € 810.000,– (or 10% of the annual turnover). This means a 180 fold higher maximum fine!

In relation to the increase of administrative fines politician Sjoera Dikkers (Dutch Labour Party – PVDA) stated: “it is clear that a fine of € 4.500,– is cheaper for practically every company, then acting in compliance with hygiene practices in the Netherlands. For a fine of € 81.000,– this can be similar for big companies, depending on the nature of the infringement. That is why we would like to further increase the maximum penalty to the sixth category. This is the only way to scare companies enough to make sure they comply with hygiene requirements.”

The exact amount of the fine will have to be proportionate and therefore depend on factors such as the number of employees, the degree of culpability, the severity of the violation and/or the turnover of an FBO. The NVWA has to assess all individual circumstances in order to establish the amount of the fine.

Final thoughts

Although relatively low fines indeed might give rise to profit for FBO’s from non-compliance and fraudulent behavior, drastically increasing the fines could have a downside for both the NVWA and the FBO’s. Imposing higher fines requires more effort and expertise from the NVWA. For fines that exceed the amount of € 340,– additional procedural requirements, similar to criminal law, have to be met by the NVWA. For FBO’s a high fine could indeed have a significant impact and even potentially mean bankruptcy. As we have seen in Dutch cases relating to the horsemeat crisis, the NVWA can impose the execution of a recall that can lead to bankruptcy. We will keep you informed on how this potential powerful enforcement instrument of high fines in the hands of the NVWA is handled in practice and dealt with in court. Hopefully, this will serve FBO’s in establishing what should be done to avoid or annul the decision of the NVWA to impose such fines, which is a part of our active practice.

The author is grateful to Floris Kets, trainee at Axon Lawyers, for his valuable contribution to this post.

The Netherlands Food and Consumer Product Safety Authority (NVWA) has been pretty active this Summer. Following up on previous enforcement reports on nutrition claims, it recently published such enforcement report re. both nutrition and health claims for breakfast cereals. As this report relates to legislation that has been harmonized at an EU-wide level and it provides detailed enforcement information, this is an interesting read – not only for the Netherlands.

Less than 50 % fully compliant

Actually, the report publishes data on the review of claims regarding 126 different breakfast cereals marketed under 24 different brands. These data were compiled during the period between March – October 2014. From this review, It appeared that less than half of those products were fully compliant with the Claims Regulation. The NVWA considers it of the essence that Food Business Operators (FBO’s) offering for sale breakfast cereals fully comply with the Claims Regulation to enable consumers to make informed choices.

Nutrition and health claim framework

Since the entry into force of the Claims Regulation on 1 July 2007, only authorized claims can be used for food products. A claim is a message or representation in any form, that is not mandatory under EU law or national legislation and that states, suggests or implies that a food has certain characteristics. A nutrition claim is a claim that states or implies that a food has particular beneficial nutritional properties in terms of energy and/or nutrients. A health claim is a claim that states or implies there is a relationship between food and health. Amongst the health claims, a distinction is made between general claims, disease risk reduction (DRR) claims and claims relating to the health and development of children. In 2012, the Commission published a list of 222 authorized general claims that is dynamic and has currently evolved into 229 claims. Furthermore, there are currently 14 authorized DRR claims and 11 children’s claims. For both nutrition and health claims, strict conditions of use are applicable. For instance, in order to claim that a product is high in proteins, at least 12 % of the energy delivered by the product should be provided by proteins.

Method of enforcement

Contrary to previous claims enforcement reports that only related to nutrition claims, the NVWA this time also took into account health claims. More concretely, it report relates to pre-packed breakfast cereals that were offered for sale in the Netherlands at both retail and wholesale level. If the products at stake were advertised at websites as well, such information was also subject to enforcement. The products at stake consisted of granola, corn flakes, puffed rice grains, oatmeal and wheat meal, some of them supplemented by nuts, sugar, dried fruits or chocolate. The information reviewed was the name of the product and the nutrition labelling, in as far as related to nutrition and health claims. A warning letter was sent to those FBO’s whose products were not compliant, except when an unauthorized claim was used. In those cases, a fine was imposed under the suspensive condition of full compliance within a grace period. When I contacted the NVWA to know the average amount of such fine, I was informed that my query would be answered within 6 weeks. Apparently, the Summer scheme is still on at NVWA – too bad. But an update will be provided at FoodHealthLegal when more information is available.

Outcome of enforcement

As mentioned above, out of the 126 products that were reviewed, over half of them did not fully comply with the Claims Regulation, mostly because the claims used were pretty vague. Although it is permitted to use a variation on an authorized claim, the essence thereof should be the same as an authorized claim. An example of a claim that was sanctioned by the NVWA is “The cereals present in this product are the basis for a healthy and nutritious breakfast. It contains nutrients that are indispensable for the human body and that are quickly absorbed by the body.” Another reason why products were not compliant was that non-existent nutrition claims were used, such as “does not contain cholesterol” or “ contains many nutrients”. Furthermore, sometimes nutrition claims were made, whereas the strict conditions of use were not met. Although this is not visible from the product label, such is a violation of the Claims Regulation as well. Finally, on many products, the link between a specific nutrient and the health claim used on the labelling was missing. Instead, pretty general, non-specific, claims were made that can be quickly taken in by the consumer, but also easily be misunderstood. Therefore, such general, non-specific claims are only allowed if accompanied by a specific, authorized, health claim. For example, the claim “Crisply granola of brand X forms part of a healthy and nutritious breakfast” cannot be used alone, but it can be used jointly with an authorized claim for iron, like “Iron contributes to normal energy-yielding metabolism”.

Recommendations

The fact that the NVWA nowadays actively enforces health and nutrition claims shows that it considers B2C communication on food product to be an integral part of food safety. From our practise I know changing the packaging of your food products is a lot of hassle, so better get it right as from the start. Here are a few tips to help you along.

At all times, it should be avoided to made a medical claim with respect to food products. Medical claims are claims directed at the prevention or treatment of a disease. Their use, if allowed at all, is strictly reserved for pharmaceuticals.

On 5 and 6 May 2015, the Vitafoods Europe Conference took place in Geneva. For companies active in the ingredient business, this is the yearly meet up to share the latest ingredients insights, to present new products and to prepare actual or future deals. Axon Lawyers was asked to participate in the Conference Program, which this year was committed to three different steams, being “your business”, “your science” and “your product” respectively. Axon Lawyers presented two topics in the business stream, pertaining to EFSA Claims and Regulatory Issues and to Labelling. Below, some background with respect to these presentations will be provided and the actual presentations will be shared.

WRAP-UP OF NOVEL FOODS PRESENTATION

Rationale of Novel Food legislation for ingredient innovations

Karin Verzijden presented a topic on the status quo of Novel Foods (NF) in the EU under the new Regulation, in which she focused on the rationale of NF legislation for ingredient innovations. As reported earlier, a new NF Regulation was presented by the Commission in December 2013, which was heavily amended based on the input from EP Rapporteur Nicholson. In November 2014, the ENVI Committee accepted draft legislation including most of the Nicholson amendments. This text represents the current status quo of NF legislation and now awaits first reading in the European Parliament (EP). The EP approved text will constitute the final legal framework.

Alternative proteins

Developments in alternative proteins, meaning proteins derived from other than animal sources, was a key trend at Vitafoods, reported FoodIngredientsFirst. Amongst those sources for alternative proteins are algae, insects and duckweed inter alia. In the presentation made at Vitafoods, the importance to know the regulatory status of each of these sources of ingredients was explained (“Begin with the end in mind“). Ingredients that have been marketed as a source of food in the EU prior to 1997 to a significant extent are clearly outside the scope of the Novel Foods Regulation. As a consequence, they are not subject to pre-market authorization, at least not based on the NF requirements. If to the contrary, no valid case for a history of safe use can be made, then it is likely that a NF authorization will have to be obtained.

Regulatory status of algae

Such history of safe use was already established for various algae, like for instance specific types of the Chlorella and Laminariaalgae. As a consequence, these ingredients can be used for food products without being subject to NF authorization, both under the current and future legal regime. The same does not apply to for instance the Rhodymenia palmata, regarding which so far only evidence on use as a food supplement is present. Such use can be of support to demonstrate the safety thereof, but as a single source will not be enough to market the product as a NF. For that purpose, it is likely that a NF authorization will have to be obtained.

Regulatory status of insects

Insects are well-known to be a rich source of proteins. Under the current NF legal framework, they are not considered to be Novel Foods, at least not explicitly so. This is likely to change under the new NF Regulation, as one of the new NF product categories reads “Food consisting of, isolated / produced from animals or their parts, including whole animals like insects, except where a history of safe use within the Union can be established”. As pointed out in one of our previous blogposts, this is contrary to the practice in some Members States, where the safety of various insects as a food ingredient has been established. Also, in practice, various insect based products are effectively marketed – examples can be found here and here. It will therefore be interesting to see if those products will be subject to enforcement measures of national health authorities. We believe that the longer those products have been marketed the more difficult this will be based on, amongst others, the principle of legal certainty.

Regulatory status of duckweed

Duckweed is reported to contain, depending on its cultivation procedure, 40 % proteins, whereas it grows much quicker than algae. Therefore this aquatic biomass could be an interesting source of alternative proteins too. Under the current legal framework, it would certainly be an option to investigate if any substantial equivalence to existing foods could be established. As a starting point, the protein RuBisCo, that occurs both in duckweed and in many green plants could be taken. If this is of no avail, it is interesting to know that under the future legal framework, the short cut authorization based on traditional foods from third countries might be available. Such will depend on the outcome of research into duckweed as a source of food in those countries, regarding which in such case a history of safe use for 25 years will have to be demonstrated.

Since the entry into force of the Food Information to Consumers Regulation (“FIC Regulation”) on 13 December 2014, some experience has been gained with the new labelling rules applicable to all food products sold to end consumers. Sofie van der Meulen presented a topic on labelling, explaining the new requirements and how these are applied in practice.

Scope

The FIC Regulation aims to modernize, simplify and clarify the food-labelling scene by recasting the horizontal labelling provisions and merging them into one single Regulation. However, labelling is still not fully harmonised due to language requirements and room for national measures, for example on allergens and additional mandatory information to be stated on the label.

The provisions of the FIC Regulation are supposed to enable consumers to choose a healthy diet and they apply to food business operators (“FBO’s”) in all stages of the food chain who supply food to the final consumer. The FBO under whose name the food is marketed or the importer into the Union market is responsible for compliance. Since a lot of products are sold via the internet nowadays, the FIC Regulation explicitly applies to online sales of food products as well. Consumers’ have to receive particular information in a webshop prior to the purchase of the food product.

Food information

In general, food information shall not be misleading, must be accurate and shall not attribute pharmaceutical characteristics to food. The latter because the food would then be covered by the medicinal products Directive.

Article 9 of the FIC Regulation lists the mandatory particulars to be stated on all labels. Where should the information be stated? With regards to prepacked food, the information should be stated directly on the product or on a label attached thereto. The information should be easily visible and clearly legible. That’s is why detailed legibility requirements are laid down in the FIC Regulation. The minimum font size of the characters should be 1.2 mm or 0.9 mm if the packaging is smaller than 80 cm2. The language used on the label should be a language that is easy understandable in the Member State where the food product is marketed. In practice most FBO’s decide to use the official language of the Member State on their labels, or, as a very minimum, on their website.

Allergens

Declaring the presence of any of the 14 listed allergenic ingredients has been a requirement since 2003. However, under the FIC Regulation the way they should be declared has changed. For prepacked foods allergens must be listed in the list of ingredients with a clear reference to the name of the allergen as listed in Annex II of the Regulation. Furthermore, the presence must be emphasized by using a different typeset that distinguishes them from the rest of the ingredients. This can be achieved by using a different font, style or background colour. The provision of allergen information for non-prepacked foods sold in, inter alia, cafes, canteens and restaurants are subject to national requirements. In the Netherlands this information can be provided orally, but for example in Ireland this information has to be provided in a written format.

Country of Origin Labelling

As of 1 April 2015 Country of Origin Labelling (‘COOL’) has been extended from beef to other unprocessed meats widely consumed in the EU. See this previous blogpost for more information on this particular extension. In the future, mandatory COOL could be further extended under the FIC Regulation and become applicable to other products such as milk and milk products and also to processed meats.

Nutrition declaration and the use of health and nutrition claims

Under the FIC Regulation, a nutrition declaration will become mandatory for most food products as from 13 December 2016. However, if health and nutrition claims are used, including a nutrition declaration on the label is already mandatory.

The nutrition declaration should state the energy value in calories and the amounts of fat, saturates, carbohydrates, sugars, protein and salt. This information should, as a main rule, be expressed per 100 g or 100 ml in order to enable the consumer to compare products and make a choice for a healthy diet. Exceptions apply to food supplements and mineral waters.

Consequences of non-compliance

Non-compliance could give rise to administrative sanctions such as administrative fines. Intended mislabelling could qualify as forgery under criminal law and be prosecuted. A Dutch meat trader was recently sentenced to 2.5 years in prison, as he was found guilty of forgery when horsemeat was not declared on the label of beef products. The Dutch Food Safety Authority currently focuses on misleading information on prepacked foods in 2015.

Both the topic of Novel Foods and Labelling is expected to evolve over time. For Novel Foods this is the case, since the legal framework has not yet been finalized. For labelling, this also applies, as the Commission still has to provide input on specific topics and also at national level, there is some room for manoeuvre. At Food Health Legal, we continue to follow and report these developments. Stay posted and do send us your comments!